Not currently registered with FDA under this name

Clinical House Europe GmbH

Bassersdorf, Switzerland. Named as applicant on 2 dental 510(k) clearances between 2013 and 2015. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
22013–2015
Markets registered in
26 registrations outside the US
Establishments
0—
2013: 12015: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Clinical House Europe GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesTaiwan: 6 registrations
RegisteredHome: SwitzerlandOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantClinical House Europe GmbH2 clearances2013–2015Below
TaiwanTFDAManufacturerCLINICAL HOUSE EUROPE GMBH62009–2015Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Clinical House Europe GmbH as the applicant.

Decided510(k)DeviceDevice type
7 Aug 2015K143758PerioType RapidDZE Root-Form Endosseous Implant
26 Apr 2013K123386PERIOTYPE X-PERTDZE Root-Form Endosseous Implant

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.